AI in healthcare policy paper

On 16 December 2025, the European Commission published the Health Package, encompassing two legislative proposals: the targeted revision of the Medical Devices Regulations (MDR/IVDR) and the Biotech Act. These proposals introduce much-needed simplification measures for medical technology and to foster the use of AI and data in health biotechnology. DIGITALEUROPE broadly welcomes these measures, as they reflect the recommendations outlined by our Health Executive Council.

As the Health Package proposals move into the ordinary legislative procedure, this position paper outlines DIGITALEUROPE’s recommendations to co-legislators to ensure that these proposals maintain the right level of ambition, foster a more digital, competitive, and patient-centric healthcare ecosystem, especially on AI-related provisions.  

As they negotiate these legislations, the European Parliament and Council of the EU should:  

• Support the European Commission’s proposed amendment to the AI Act within the MDR/IVDR targeted revision (moving MDR/IVDR from Section A to Section B of AI Act Annex I), and further fine-tune it by clarifying a timeline for the integration of respective high-risk obligations into MDR/IVDR (see pages 4-5) via delegated acts;  

• Better align the Biotech Act with the AI Act, as well as further clarify its data-sharing requirements and modalities with those outlined in the EHDS to ensure legal clarity across legislation;  

• Avoid overly broad disclosure requirements on AI uses in the context of clinical trials when these do not pose risk to patients or have high regulatory impact & ensure guidelines on AI use in Biotech and clinical trials are closely developed with industry;  

• Support and further refine the European Commission proposed amendments to the Clinical Trials Regulation (CTR) around the legal basis for processing health data in the context of clinical trials;  

The document further provides a list of amendments to the proposed MDR/IVDR revision that would support a more balanced classification of software as a medical device and would facilitate the digitalisation of healthcare more broadly. These can be found in the Annex.